FDA 510(k) Pre-Submission: Steps for Medical Device Approval
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
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NHP
| Food See All | Medical Devices
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OTC Drug
| Cosmetics
| Veterinary Health Products
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Disinfectant
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We take a personal approach to every client’s needs and goals. Our mission is to see your business thrive through compliance and risk mitigation. With a team of former FDA and Health Canada regulatory agency officials, regulatory experts, quality assurance specialists and industry professionals we provide insights and strategies to navigate the complex journey of regulations to help you make clear, decisive decisions to grow your business.
Your business and compliance needs are our priority. By first educating you about the regulatory requirements, then outlining how our solutions complement your strategy, our best-in-class approach helps your business grow.
Our team, consisting of former government agents to industry professionals, our knowledge and situations will guide your business in the right direction, ensure you comply and mitigate risk.
Our sister company, Quality IMPORT Solutions, holds a Health Canada licence to import Natural Health Products and a CFIA license to import conventional and supplemented foods.
We support your domestic and international growth by offering regulatory solutions both in-house and with our extensive international compliance network partners so you comply with the applicable jurisdiction's regulations.
We serve global clients from our North American headquarters by offering trusted compliance services.
I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.